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FDA 510(k)

FemVue® Controlled Saline-Air Device (FSA-300)

K-Number: K253403 · 2025-12-15

ApplicantFemasys, Inc.
Decision Date2025-12-15
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FemVue® Controlled Saline-Air Device (FSA-300) is the device name listed in this FDA 510(k) record. The listed applicant is Femasys, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K253403. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FemVue® Controlled Saline-Air Device (FSA-300)?

FemVue® Controlled Saline-Air Device (FSA-300) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Femasys, Inc.. The 510(k) number is K253403.

When did FemVue® Controlled Saline-Air Device (FSA-300) receive FDA 510(k) clearance?

FemVue® Controlled Saline-Air Device (FSA-300) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253403.

Who is the listed applicant for FemVue® Controlled Saline-Air Device (FSA-300)?

The FDA 510(k) record lists Femasys, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FemVue® Controlled Saline-Air Device (FSA-300)?

The FDA product code for FemVue® Controlled Saline-Air Device (FSA-300) is LKF.

Other records listing Femasys, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242002FemVue MINI Saline-Air DeviceK241693FemChec Controlled Saline-Air Device (FCD-250)K231730FemaSeed Intratubal Insemination

Related Devices (Code: LKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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